CLASS II ONGOING Device recall · Reported 20 Dec 2023 · FDA Enforcement Report
The 4Kscore Test, an in vitro serum or plasma test that recalled
BioReference Health is recalling The 4Kscore Test, an in vitro serum or plasma test that combines the results of four, distributed nationwide in the US. The recall was initiated on 31 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0516-2024
- FDA event ID
- 93050
- Recalling firm
- BioReference Health, Elmwood Park, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Oct 2023
- FDA classified
- 8 Dec 2023
- Reported
- 20 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 31 Oct 2023 | Recall initiated by company | |
| 8 Dec 2023 | Classified by FDA | +38 days |
| 20 Dec 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mathematical modeling of the 4Kscore with and without DRE information was recently performed on over 3,000 specimens. DRE information is a required component of The 4Kscore Test.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following information: a patient s age, previous biopsy, and digital rectal exam (DRE).
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is The 4Kscore Test, an in vitro serum or plasma test that combines the results of four recalled?
Yes. BioReference Health recalled The 4Kscore Test, an in vitro serum or plasma test that combines the results of four on 31 Oct 2023. The recall is Class II and its status is Ongoing. Recall number Z-0516-2024.
Why was it recalled?
Mathematical modeling of the 4Kscore with and without DRE information was recently performed on over 3,000 specimens. DRE information is a required component of The 4Kscore Test.
Which lots are affected?
UDI-DI: 00850038860004
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from BioReference Health
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | The 4Kscore Test is an in vitro serum or plasma test that recalled | BioReference Health | Lead & Heavy Metals | Nationwide |
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